ISO 15189评审自动生化分析仪使用中的常见不符合项及解决方案

Frequently nonconformities and solutions in the use of chemistry analyzer in ISO 15189 assessment

通过分析ISO 15189评审中的常见不符合案例,阐述目前自动生化分析仪日常使用过程中的主要问题。同时依据ISO 15189准则及相关专业领域应用说明的要求,提出了合理的纠正措施建议,以帮助临床实验室更好地使用、保养、维修和校准设备,减低故障,保证结果的准确性。同时也为深入理解ISO 15189条款提供了有益的借鉴。

To present the main problems in the use of chemistry analyzing daily, through analyzingthe common nonconformities in ISO 15189 assessment. We put forward the reasonable advices in corrective action, according to the ISO 15189 standard and the guidance on the application in chemistry. To help the laboratory improve the use of analyzer in operation, maintenance, repair. To reduce the troubleshooting, and to ensure the accuracy. This paper also provides the beneficial reference for the deep understanding of the terms of ISO 15189.